ISO 17025 - Recommended or Required and other Calibration questions

[Mark M. Sweeny]

Hello.

First, I want to say thank you for the value of this forum. It has helped me out of many difficult situations and I am most appreciative.

Several questions about calibration and 17025.

1. During a customer audit, my client was asked if its calibration house was ISO 17025. Is 17025 required or is it recommended for calibration houses?

2. How are equipment tolerances determined? Are they determined by the calibration house, the manufacturer of the equipment or the company requesting the calibration? How is this typically specified in a calibration procedure?

3. My client takes a risk based approach to calibration by calibrating equipment annually. Their customer is saying that there are industry standards requiring more frequent calibrations. For example, pipettes should be calibrated quarterly. What institution sets standards for thermometers, WUTCs, centrifuges, pipettes? Are these requirements or guidelines? Can my client do a risk-base approach and only calibrate equipment once a year?

Once again, thank you for all your help. It is much appreciated.

Mark

 

[BradM]

Hello Mark! I'll give these questions a shot.

1. During a customer audit, my client was asked if its calibration house was ISO 17025. Is 17025 required or is it recommended for calibration houses?

17025 is a really good standard for commercial calibration labs. Primarily, it has a demonstrated proficiency component of it, that can give customers some confidence that an auditor has observed their technical capabilities and such. I think it is required for calibration vendors in the automotive industry, but I am not in that industry so I'm kind of going off what I have read here in other places. Other than that, I'm not sure about the "requirement" component of it.

2. How are equipment tolerances determined? Are they determined by the calibration house, the manufacturer of the equipment or the company requesting the calibration? How is this typically specified in a calibration procedure?

That's actually a really good question. Tolerances can some from a number of sources that you mentioned. However, most of the time when someone is calibrating something for you, you can specify the tolerance. Most of the time calibration providers will tend to rely on mfg. tolerances. However, a lot of time a process requirement can be used. If you have a digital pressure gauge that is +/-.1 PSI mfg. tolerance but you only need to to achieve +/-.5 PSI, then you could make the .5 the calibration tolerance.

3. My client takes a risk based approach to calibration by calibrating equipment annually. Their customer is saying that there are industry standards requiring more frequent calibrations. For example, pipettes should be calibrated quarterly. What institution sets standards for thermometers, WUTCs, centrifuges, pipettes? Are these requirements or guidelines? Can my client do a risk-base approach and only calibrate equipment once a year?

I don't know of a whole lot of industry standards that specify calibration intervals. However, there are regulatory standards (like in Aerospace) that will dictate certain frequencies.

So I usually follow this priority list:
1. Regulatory requirements
2. ISO/ANSI national standards
3. Mfg. specifications/recommended practices
4. Process requirement

So saying, you can set your own test points and tolerances, unless there is a really clear regulatory requirement, or an ANSI/ISO guideline (like with pipettes), and so on.
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You have asked some really good questions, Mark. If you client has been having their instruments calibrated, there have not been a lot of failures associated with calibration, the calibrated instruments provide the needed accuracy/ confidence, and your client is compliant with any/all regulatory requirements, I think their risk-based approach and such should be fine.

 

[Mark M. Sweeny]

Thanks Brad....very helpful.
Quick question...is there an ANSI/ISO guidelines for calibration of pipettes? If so, what is the guideline? How often should pipettes be calibrated according to this guideline?

 

[Jim Wynne]

Thanks Brad....very helpful.
Quick question...is there an ANSI/ISO guidelines for calibration of pipettes? If so, what is the guideline? How often should pipettes be calibrated according to this guideline?

From the document abstract on the ISO website:

ISO 8655-2:2002 specifies metrological requirements, maximum permissible errors, requirements for marking and information to be provided for users, for air-displacement (type A) and positive-displacement (type D) single-channel and multi-channel piston pipettes, complete with their selected tip(s) and any other essential, consumable parts, designed to deliver their specified nominal volume (Ex).

 

[BradM]

Thanks Brad....very helpful.
Quick question...is there an ANSI/ISO guidelines for calibration of pipettes? If so, what is the guideline? How often should pipettes be calibrated according to this guideline?

Mark, I don't think I recall that standard specifically mandating how often calibration of pipettes should be conducted.

I can try to look through it in detail tomorrow, if that would be helpful to you.

 

[Mark M. Sweeny]

Thanks Brad...that is very nice of you.

However, I think I am good to go.

Thanks for the direction.

Mark